Pharmacovigilance Specialist

3 weeks ago


Singapore Integrity Partners Pte. Ltd. Full time

An exciting opportunity with a global pharmaceutical company driving advancements through scientific research in areas of need and has strong portfolios of products across multiple therapeutic areas. They are currently seeking a Pharmacovigilance Specialist to join their pharmacovigilance team.

The successful incumbent will be tasked to perform and contribute to pharmacovigilance activities such as individual case safety report and aggregate safety monitoring, AE reporting, risk-benefit assessment, risk management planning and strategy, and execution of post-marketing commitments while ensuring compliance with global regulatory requirements.

Main Responsibilites
  • PV audit handling and ensuring inspection readiness
  • Cultivate and maintain PV awareness and performing necessary PV trainings
  • Maintenance of local market safety data quality
  • Provide safety information and updates on emerging pharmacovigilance or patient safety issues
  • Ensure compliance and adherence to Pharmacovigilance Agreements
  • Risk management plans submissions including additional risk minimization materials to relevant health authorities
  • Post-marketing adverse events processing including collection, follow-up and submissions to local health authories and ethic committees of post-marketing AE from spontaneous, literature or solicited sources as applicable.
Requirements
  • Relevant Bachelor Degree (e.g. life science, pharmacy, nursing)
  • At least 1-2 years' experience in the pharmaceutical industry.
  • Experience in pharmacovigilance and/or regulatory affairs is highly advantageous.
  • Strong organizational, faciliation and interpersonal skills.
Next Steps

Interested applicants may apply directly with your most recent CV in word format and we shall get in touch shortly for a confidential discussion on this exciting opportunity.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502



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